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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Eliglustat intermediate 4 Eliglustat intermediate 4 491833-27-3 C23H30N2O4
2-[(4-Acetylphenyl)methyl]cyclopentan-1-one 2-[(4-Acetylphenyl)methyl]cyclopentan-1-one 96824-28-1 C14H16O2
Dapoxetine Impurity 1 Dapoxetine Impurity 1 119357-22-1 C22H25NO
Mirabegron Impurity 5 Mirabegron Impurity 5
Milrinone Impurity 5 Milrinone Impurity 5
Solifenacin Related Compound 20 Solifenacin Related Compound 20 1300713-32-9 C17H17NO
Cefuroxime Impurity 2 Cefuroxime Impurity 2 C16H16N4O8S
Cefoxitin Impurity 1 Cefoxitin Impurity 1
Cefazolin Impurity 1 Cefazolin Impurity 1
Umeclidinium Bromide Impurity 8 Umeclidinium Bromide Impurity 8 869113-10-0 C27H30BrNO
Nifuratel impurity E Nifuratel impurity E
Valsartan Impurity 14 Valsartan Impurity 14 C24H29N5O3
Istradefylline Impurity 4 Istradefylline Impurity 4
Zolmitriptan Impurity 2 Zolmitriptan Impurity 2
Atazanavir Impurity  6 Atazanavir Impurity 6 1006868-81-0 C32H42N4O5
Palbociclib Impurity 9 Palbociclib Impurity 9 2204368-66-9 C24H29N7O2
Solifenacin Impurity 1 Solifenacin Impurity 1 1353274-25-5 C19H21NO2
Vildagliptin Methyl Ester Vildagliptin Methyl Ester
Flucloxacillin Impurity B Flucloxacillin Impurity B
Ropinirole impurity Ropinirole impurity
Mupirocin iMpurity B Mupirocin iMpurity B C26H44O9
Nicorandil Impurity 2 Nicorandil Impurity 2
Piperacillin Impurity 7 Piperacillin Impurity 7
Defluoro Paroxetine Hydrochloride Defluoro Paroxetine Hydrochloride 1394842-91-1
Afatinib Impurity 15 Afatinib Impurity 15
Milnacipran Impurity 11 Milnacipran Impurity 11 1410831-12-7 C11H10O2
Mirabegron Impurity 18 Mirabegron Impurity 18
Atorvastatin lactone Atorvastatin lactone 125995-03-1 C33H33FN2O4
Prucalopride Impurity F Prucalopride Impurity F 1900715-98-1 C18H26ClN3O4
tert-butyl (R)-3-(hydroxymethyl)hexanoate tert-butyl (R)-3-(hydroxymethyl)hexanoate 1928755-17-2 C11H22O3
Alfuzosin Alfuzosin 19216-53-6 C12H16N4O2
Alfuzosin Alfuzosin 19216-53-6 C12H16N4O2
4-[[3-Chloro-4-(2-pyridinylmethoxy)phenyl]amino]-7-ethoxy-6-[(1-methyl-2-pyrrolidinylidene)amino]-3-quinolinecarbonitrile 4-[[3-Chloro-4-(2-pyridinylmethoxy)phenyl]amino]-7-ethoxy-6-[(1-methyl-2-pyrrolidinylidene)amino]-3-quinolinecarbonitrile 1144516-21-1 C29H27ClN6O2
Sofosbuvir Impurity 5 Sofosbuvir Impurity 5
ethyl (S)-2-(2-oxopyrrolidin-1-yl)butanoate ethyl (S)-2-(2-oxopyrrolidin-1-yl)butanoate 1862335-58-7 C9H16ClNO3
vildagliptin Impurity R vildagliptin Impurity R 1803168-09-3 C7H8Cl2N2O
2-chloromethyl-4-(3-hydroxypropoxy)-3-methylpyridine 2-chloromethyl-4-(3-hydroxypropoxy)-3-methylpyridine 117976-92-8 C10H14ClNO2
8-Methoxy Entecavir 8-Methoxy Entecavir 2203740-23-0 C13H17N5O4
Bortezomib Impurity 32 Bortezomib Impurity 32 1310383-72-2 C17H31BF3NO5
Topiroxostat Impurity 14 Topiroxostat Impurity 14
1-Pyrrolidinecarboxylic acid, 4-hydroxy-2-(3-thiazolidinylcarbonyl)-, 1,1-dimethylethyl ester, (2S,4S)- 1-Pyrrolidinecarboxylic acid, 4-hydroxy-2-(3-thiazolidinylcarbonyl)-, 1,1-dimethylethyl ester, (2S,4S)- 401564-34-9 C13H22N2O4S
Ampicillin Impurity B Ampicillin Impurity B
Clindamycin Phosphate EP Impurity K Clindamycin Phosphate EP Impurity K
UGDFSHGFPJSALM-OCKHKDLRSA-N UGDFSHGFPJSALM-OCKHKDLRSA-N 113806-01-2 C22H25NO3
Homoeriodictyol 7-O-glucoside Homoeriodictyol 7-O-glucoside 14982-11-7 C22H24O11
7,7'-(butane-1,4-diylbis(oxy))bis(quinolin-2(1H)-one) 7,7'-(butane-1,4-diylbis(oxy))bis(quinolin-2(1H)-one) 2116542-19-7 C22H20N2O4
Descyclopropyl Lenvatinib Descyclopropyl Lenvatinib 417719-51-8 C18H15ClN4O4
Fesoterodine Impurity 8 Fesoterodine Impurity 8 1380491-71-3 C48H66N2O4
QBWNUEJPRUVNTD-FOIQADDNSA-N QBWNUEJPRUVNTD-FOIQADDNSA-N 1346602-17-2 C22H17N3O5
JZWUWLJCMMPASK-YTSMVRMISA-N JZWUWLJCMMPASK-YTSMVRMISA-N 147103-95-5 C24H24N4O7S
KXEITTOLAUJQPU-UHFFFAOYSA-N KXEITTOLAUJQPU-UHFFFAOYSA-N 1797832-43-9 C20H21N7O2S
GPZGXSFHPLUMHE-KEUNHQLVSA-N GPZGXSFHPLUMHE-KEUNHQLVSA-N 157054-84-7 C52H81NO13
IRLGOHSHDYCIAB-ZMVBZRCWSA-N IRLGOHSHDYCIAB-ZMVBZRCWSA-N 1076198-14-5 C19H23F3N2O5
AOEGVETYSHPGBP-XYIDDFOTSA-N AOEGVETYSHPGBP-XYIDDFOTSA-N 1887057-05-7 C41H55NO14
1,3,5,7-Tetranitroadamantane 1,3,5,7-Tetranitroadamantane 75476-36-7 C10H12N4O8
Fexofenadinone Fexofenadinone 76811-98-8 C32H37NO4
Bupivacaine  Impurity Bupivacaine Impurity 780736-98-3 C14H20N2O
rel-(4aR,7aR)-6-Benzyloctahydro-1H-pyrrolo[3,4-b]pyridine rel-(4aR,7aR)-6-Benzyloctahydro-1H-pyrrolo[3,4-b]pyridine 161594-54-3 C14H20N2
1,2-bis(4-(3-(trifluoromethyl)phenyl)piperazin-1-yl)ethane 1,2-bis(4-(3-(trifluoromethyl)phenyl)piperazin-1-yl)ethane 51299-16-2 C24H28F6N4
(R)-N-(1-(7,8-dihydronaphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine (R)-N-(1-(7,8-dihydronaphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine 802918-35-0 C22H24F3N
Demiditraz racemate Demiditraz racemate 944263-08-5 C13H16N2
Ropivacaine-iPr Ropivacaine-iPr 175888-75-2 C17H26N2O
Demiditraz IMpurity Demiditraz IMpurity 944267-48-5 C19H18N2O
Apremilast impurity 18 Apremilast impurity 18 1407140-51-5 C20H32N2O6S
Betamethasone EP Impurity F Betamethasone EP Impurity F 330157-04-5 C22H28O4
Capecitabine Impurity 8 Capecitabine Impurity 8
Carfilzomib Impurity D Carfilzomib Impurity D
Cefodizime Impurity 4 Cefodizime Impurity 4
Cefradine impurity 5 Cefradine impurity 5 1379292-16-6 C10H17NO2
Clopidogrel Impurity 13 Clopidogrel Impurity 13 2173294-69-2 C16H16ClNO5S2
DecitaBine Impurity 12 DecitaBine Impurity 12
Erlotinib Impurity 28 Erlotinib Impurity 28
Fosaprepitant Impurity 12 Fosaprepitant Impurity 12 172673-19-7 C23H22F7N4O6P
Ibuprofen Impurity 2 Ibuprofen Impurity 2 C13H18O2
Imatinib Impurity 9 Imatinib Impurity 9
Isavuconazole Impurity 22 Isavuconazole Impurity 22
Isavuconazole Impurity 28 Isavuconazole Impurity 28
Levothyroxine Impurity 16 Levothyroxine Impurity 16 909279-46-5 C15H11ClI3NO4
Linagliptin Impurity 42 Linagliptin Impurity 42
PalBociclib Impurity 25 PalBociclib Impurity 25
Posaconazole Impurity 13 Posaconazole Impurity 13 357189-98-1 C37H40F2N8O6
Posaconazole Impurity 25 Posaconazole Impurity 25 1042398-26-4 C16H19F2IO3
Posaconazole Impurity 42 Posaconazole Impurity 42 357189-96-9 C36H40F2N8O5
Posaconazole Impurity 65 Posaconazole Impurity 65 2947625-11-6 C60H69F2N13O7
Pramipexole Dimer Impurity (Mixture of Diastereomers) Pramipexole Dimer Impurity (Mixture of Diastereomers) 1147937-31-2 C13H23N3S
Sitafloxacin Impurity 1 Sitafloxacin Impurity 1 C19H19ClF2N4O2
Sitagliptin Impurity 25 Sitagliptin Impurity 25
sofosBuvir impurity 47 sofosBuvir impurity 47
SofosBuvir Impurity 64 SofosBuvir Impurity 64
Tofacitinib Impurity W Tofacitinib Impurity W
Trelagliptin Impurity 21 Trelagliptin Impurity 21
3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)-rel- 3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)-rel- 54088-21-0 C13H18FNO
1'-Hydroxy Bilastine 1'-Hydroxy Bilastine 1638785-23-5 C28H37N3O4
Brexpiprazole Impurity 4 Brexpiprazole Impurity 4 2116542-20-0 C25H27N3O2S
Fosaprepitant Impurity 5 Fosaprepitant Impurity 5 327623-35-8 C21H19F6NO3
Moxifloxacin Ethyl Ester Moxifloxacin Ethyl Ester 1403836-23-6 C23H28FN3O4
Pantoprazole Impurity 5 Pantoprazole Impurity 5 1806469-15-7 C8H6F2N2O2
Venlafaxine Impurity 5 Venlafaxine Impurity 5 1346600-77-8 C17H27NO2
N-(4-methyl-3-(4-methyl-6-(pyridin-3-yl)pyrimidin-2-ylamino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide N-(4-methyl-3-(4-methyl-6-(pyridin-3-yl)pyrimidin-2-ylamino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide C30H33N7O
Exemestane impurity B -F Exemestane impurity B -F 184972-09-6 C20H26O3
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